Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00009542
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-01-27
Brief Title:
Effects of Kava on the Bodys Elimination of Caffeine and Dextromethorphan
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Evaluation of the Effect of Kava on Drug Metabolism Enzymes and EEG Measured Beta Amplitude
Status:
COMPLETED
Status Verified Date:
2001-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will examine how kava-a widely used herbal remedy-may affect the bodys elimination of other medicines Many people take kava to reduce anxiety or cause sedation Since this product is considered a food supplement and not a drug it is not subject to the rigorous pre-market testing required for prescription and over-the-counter OTC drugs As a result information has not been collected on possible interactions between kava and other medications This study will look at how kava affects the elimination of caffeine-a compound commonly found in chocolate coffee tea and soft drinks-and dextromethorphan-an OTC cough suppressant
Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study Candidates will provide a medical history and undergo a physical examination and routine blood tests Women of childbearing age will have a urine pregnancy test
Study participants will not drink alcoholic beverages or take any medications except those given in the study for 2 weeks prior to the study and throughout its duration In addition they will abstain from caffeine grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected
On day 1 of the study study subjects will take one dose each of caffeine and dextromethorphan at 400 PM They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine They will bring the urine samples to the Clinical Center when the collection is complete This procedure will be repeated 1 week later study day 8 After the second urine collection is completed subjects will take 200 milligrams of kava 3 times a day for 21 days On study day 29 after 21 days of kava subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above while continuing to take kava
Subjects will have an electroencephalograph EEG done before starting kava and again at the end of kava study day 30 For this procedure several electrodes metal cups attached to wires are secured to the scalp with a glue-like substance A conductive gel fills the space between the electrode and the scalp to ensure good contact The electrodes will remain in place for about 2 hours and then removed The subject lies quietly on a bed during the EEG recording
Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection
Normal healthy volunteers 21 years of age or older may be eligible for this 30-day study Candidates will provide a medical history and undergo a physical examination and routine blood tests Women of childbearing age will have a urine pregnancy test
Study participants will not drink alcoholic beverages or take any medications except those given in the study for 2 weeks prior to the study and throughout its duration In addition they will abstain from caffeine grapefruit and grapefruit juice and charbroiled foods for at least 72 hours before and throughout each study day that urine is collected
On day 1 of the study study subjects will take one dose each of caffeine and dextromethorphan at 400 PM They will empty their bladder before the dosing and then collect all their urine after the dosing for the rest of the day and including the next mornings first urine They will bring the urine samples to the Clinical Center when the collection is complete This procedure will be repeated 1 week later study day 8 After the second urine collection is completed subjects will take 200 milligrams of kava 3 times a day for 21 days On study day 29 after 21 days of kava subjects will repeat the dextromethorphan and caffeine dosing and urine collection described above while continuing to take kava
Subjects will have an electroencephalograph EEG done before starting kava and again at the end of kava study day 30 For this procedure several electrodes metal cups attached to wires are secured to the scalp with a glue-like substance A conductive gel fills the space between the electrode and the scalp to ensure good contact The electrodes will remain in place for about 2 hours and then removed The subject lies quietly on a bed during the EEG recording
Participation in the study will end with another physical examination and blood tests following the second EEG and urine collection
Detailed Description:
Kava piper methysticum is a complementary or alternative medication used for purported anxiolytic and sedative effects Despite its widespread use there is no data regarding potential for drug interactions or its effects on the electroencephalogram The purpose of this study is to determine the effect of administration of kava for 3 weeks on the activity of cytochrome p450 1A2 2D6 3A4 NAT2 and XO Additionally the effect of kava on EEG measured beta amplitude will be evaluated Fifteen healthy volunteers will undergo enzyme activity phenotyping by ingesting 2 mgkg of caffeine and 30 mg of dextromethorphan followed by an overnight urine collection Following completion of two separate baseline evaluations separated by 1 week subjects will then take 1 capsule containing 60 mg of kavalactones three times daily for 3 weeks Following 3 weeks of therapy subjects will undergo repeat enzyme activity phenotyping as described previously Enzyme activity following 3 weeks of kava will be compared to pre-treatment values to characterize the magnitude of inhibition andor induction of CYP1A2 CYP2D6 CYP3A4 NAT2 and XO activity Additionally subjects will have EEG testing performed to evaluate the effect of kava on beta amplitude EEGs will be performed the day before the first baseline phenotyping procedure and then following three weeks of kava the day before the final phenotyping procedure Beta amplitude following three weeks of kava will be compared to pre-treatment values to evaluate the magnitude of pharmacodynamic effect The results of this study will be used to facilitate the development of protocols to evaluate the magnitude of interactions between clinically relevant traditional medications and kava as well as studies to compare the pharmacologic effect of kava to the effects of benzodiazepines
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-CC-0059 | None | None | None |